Director, Regulatory Affairs, North America

VWR International, LLC, a global laboratory supply and distribution company, is headquartered in West Chester, PA with worldwide sales of $3.5 billion and employs over 6,500 associates in over 20 countries.
    VWR enables science by supplying most of the world’s top pharmaceutical and bio companies, as well as industrial, educational and governmental organizations with the equipment, products and onsite services they need to advance critical research. With over 150 years of industry experience, VWR offers a well-established distribution network that reaches thousands of specialized labs and facilities across the globe. With a client base spanning North America, Europe, and Asia, VWR is firmly positioned to maintain a strong global presence. The company’s internationally recognized approach to customer service provides competitive pricing and on-demand delivery for an expansive breadth of inventory.
In addition to a competitive salary, we offer our associates a wide range of benefits designed to help them stay healthy, plan for the future, prepare for the unexpected and balance the demands of work and home. VWR offers an outstanding benefits package that includes: a 401(k) plan with a generous company matching contribution, medical, dental, life insurance, short and long term disability, EAP (employee assistance program), flexible spending account, holiday/vacation time, work/life balance programs, education assistance and a credit union.
  At VWR International, we realize our associates are a large part of who we are and how we succeed. We value the accomplishments of our associates, and offer them true, long lasting opportunities for growth and success. As a result we have many associates who have remained with us for 10, 20, and 30 years. Their loyalty is a direct result of all we have to offer: great compensation, a warm culture, and real opportunities for growth and success! VWR International is a great place to work and we look forward to adding more outstanding members to our team!

JOB DESCRIPTION:
Provides overall management for Regulatory Affairs in North America. Duties include management of Import and Export compliance of products and services to and from North America with offices in West Chester, PA and Arlington, IL. Leads VWR International, LLC efforts to comply with all regulations governing the purchase, storage, sale and transportation of extensive product lines sold by VWR and its subsidiaries.Supervision of direct reports including the setting of realistic goals, monitoring progress and validation of their proposed path forward to resolve problems. Making adjustments to priorities in a very dynamic environment. Interface with other VWR departments to advise them of the regulatory requirements associated with each department and the changes and/or addition of business they propose to undertake. Analyze the impact of these changes on VWR including regulatory compliance, customer satisfaction and VWR profitability to the extent these parameters are tied to full regulatory compliance. Monitor total workload, complexity of changes required and budget to make the best possible use of available resources including existing staff, temporary help, consultants and outside lawyers. Personally monitor regulatory change and increase understanding of existing regulations for the diverse products that VWR sells.Develop/revise Corporate Standards to ensure regulatory compliance. Ensure that all are updated as needed, and provide guidance on development of business/field SOP’s.

JOB REQUIREMENTS:
Bachelor of Science in chemistry, biochemistry, pharmacology, microbiology or related fields. Advanced degree in science or regulatory compliance is preferred.

6-9 years experience in regulatory field and experience with interfacing with regulatory agencies.
 

5 years supervisory experience.
 

Working knowledge of the following regulatory areas highly desirable: Transportation of hazardous materials such as DOT, IATA and/or TDG. Environmental compliance, such as, EPA hazardous waste disposal or RMP. Security Regulations, such as, CFATS. OSHA Employee Right-To-Know, chemical labeling and MSDS requirements. FDA compliance for medical devices and drugs.

DESIRED EXPERIENCE:

6 -9 yrs in regulatory field and experience interfacing with agencies.5 years supervisory experience.

EDUCATION:

Bachelor of Science in chemistry, biochemistry, pharmacology, microbiology or related fields. Advanced degree in science or regulatory compliance is preferred.

EOE M/F/D/V
VWR maintains a drug-free workplace
VWR and design are registered trademarks of VWR International, LLC
VWR International, LLC is aware of fraudulent e-mails referencing VWR job opportunities.
Please note:
VWR does not hire employees through e-mail solicitation and never requests any employee to cash money orders or send money to others. If you question the legitimacy of a job opportunity, you can verify all job opportunities for the US and Canada by calling the VWR Career Center.

Please refer to job code 493 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	West Chester, PA
County:	Chester County
ZIP Code:	19380
Pay Rate:	Open
Job Terms:	full time
Company:	VWR International
Phone:	Apply Online Only
Fax:	ApplyOnline Only
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